Current philosophical perspectives on drug approval in the real world

Abstract

Abstract The evidence-based medicine approach to causal medical inference is the dominant account among medical methodologists. Competing approaches originating in the philosophy of medicine seek to challenge this account. In order to see how successful these challenges are, we need to assess the performance of all approaches in real world medical inference. One important real world problem all approaches could be applied to is the assessment of drugs for approval by drug regulation agencies. This study assesses the success of the status quo against an empirical non-systematically obtained body of evidence and we scrutinise the alternative approaches from the armchair, contemplating how they would fare in the real world. We tentatively conclude that the status quo is regularly not successful at its primary task as it regularly fails to correctly assess effectiveness and safety and suggest that this is due to inherent factors of the “messy real world.” However, while all alternatives hold promise, they are at least as susceptible to the real world issues that beset the status quo. We also make recommendations for changes to current drug approval procedures, identify lacunae to fill in the alternatives, and finally, call for a continuation of the development of alternative approaches to causal medical inference and recommendations for changes to current drug approval procedures.